International Medical Devices Database

Manufacturer Address
AmniSure International LLC, 31 Sacramento St # 5, Cambridge MA 02138-1820
Manufacturer Parent Company (2017)
QIAGEN N.V.
Source
USFDA
1 Event
- Recall of AmniSure

One device in the database

AmniSure

Model / Serial
Lot Number/ Exp. Date A7003, 01/2009. A7002, 11/2008, A7001, 10/2008, A6005, 04/2008, A6004, 01/2008, A6003, 09/2007, and A6002-3, 09/2007
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
1
Implanted device?
No
Distribution
Worldwide, USA, Australia, Austria, Italy, Korea, Bulgaria, Russia, Spain, Kuwait, Switzerland, Luexemburg, Ireland, Denmark, Netherlands, Jordan, Israel, Chile, UK, Singapore, Basil, New Zealand, Turkey, France, Greece, and Equador
Product Description
AmniSure ROM Test, Fetal Membrane Rupture Test for || In-Vitro Diagnostic Use, Model: FMRT-1, AmniSure International LLC, Cambridge, MA 02138

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Disclaimer

Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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AmniSure International LLC

One device in the database

AmniSure